1. Field of the Invention
The present invention is directed to pharmaceutical formulations comprising agents capable of inhibiting interleukin-1 (IL-1), and to methods for making and using such formulations. The invention is directed to pharmaceutical formulations having increased stability.
2. Statement of Related Art
Interleukin-1 (IL-1) antagonists capable of blocking or inhibiting the biological action of IL-1, have been described. An example IL-1 antagonist, an IL-1 trap, is described in U.S. Patent Publication No. 2003/0143697, published 31 Jul. 2003, herein specifically incorporated by reference in its entirety. An IL-1 trap is an IL-1-specific fusion protein comprising two IL-1 receptor components and a multimerizing component.
Lyophilization (freeze drying under controlled conditions) is commonly used for long term storage of proteins. The lyophilized protein is substantially resistant to degradation, aggregation, oxidation, and other degenerative processes while in the freeze dried state (see, for example, U.S. Pat. No. 6,436,897).